Novabone Products, LLC: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Novabone Products, LLC” (first 2002, latest 2024), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 71 days. Since 2017 the median was 55 days, against 124 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 152 |
| 2015 | 2 | 69 |
| 2016 | 0 | — |
| 2017 | 1 | 56 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 472 |
| 2024 | 2 | 40 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Novabone Products, LLC took a median 55 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 19 | 19 |
| LYC | Bone Grafting Material, Synthetic | 9 | 9 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
Review panels
- Orthopedic (19)
- Dental (9)
- General and Plastic Surgery (2)
Most recent Novabone Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | MQV | 2024-09-25 | 54 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | MQV | 2024-03-05 | 25 |
| K220498 | NovoGen Wound Matrix | KGN | 2023-06-09 | 472 |
| K163310 | NovaBone IRM | MQV | 2017-01-18 | 56 |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) | MQV | 2015-08-26 | 30 |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | KGN | 2015-01-08 | 108 |
| K141207 | NOVABONE BIOACTIVE STRIP | MQV | 2014-10-31 | 175 |
| K140946 | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE | MQV | 2014-08-22 | 130 |
| K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | LYC | 2011-12-16 | 115 |
| K112773 | NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT | MQV | 2011-10-14 | 21 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Novabone Products, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Novabone Products, LLC?
FDA lists 30 510(k) clearances under the applicant name “Novabone Products, LLC” (first 2002, latest 2024), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Novabone Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novabone Products, LLC is 71 days. Since 2017: 55 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Novabone Products, LLC?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 19); LYC (Bone Grafting Material, Synthetic, 9); KGN (Wound Dressing With Animal-Derived Material(S), 2).
Next steps
- See all 30 Novabone Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQV, Novabone Products, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.